➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
Colorcon
Express Scripts
Moodys
Medtronic
Merck

Last Updated: August 3, 2021

DrugPatentWatch Database Preview

Risperidone - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

What are the generic sources for risperidone and what is the scope of freedom to operate?

Risperidone is the generic ingredient in four branded drugs marketed by Indivior Inc, Janssen Pharms, Amneal Pharms, Ani Pharms, Aurobindo Pharma Ltd, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Taro, Torrent, Tris Pharma Inc, Wockhardt, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Heritage Pharma, Jubilant Generics, Mylan Pharms Inc, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Amneal, Apotex Inc, Celltrion, Chartwell Molecular, Jubilant Cadista, Mylan, Prinston Inc, Ratiopharm, Renata, Rising, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in forty-nine NDAs. There are seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risperidone has thirty-eight patent family members in seventeen countries.

There are thirty drug master file entries for risperidone. Thirty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for risperidone

See drug prices for risperidone

Drug Sales Revenue Trends for risperidone

See drug sales revenues for risperidone

Recent Clinical Trials for risperidone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of ChicagoPhase 4
Beth Israel Deaconess Medical CenterPhase 4
University of GeorgiaPhase 4

See all risperidone clinical trials

Generic filers with tentative approvals for RISPERIDONE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free1MG/MLSOLUTION; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for risperidone
Medical Subject Heading (MeSH) Categories for risperidone
Paragraph IV (Patent) Challenges for RISPERIDONE
Tradename Dosage Ingredient NDA Submissiondate
RISPERDAL TABLET, ORALLY DISINTEGRATING;ORAL risperidone 021444 2005-04-11
RISPERDAL TABLET, ORALLY DISINTEGRATING;ORAL risperidone 021444 2005-03-23
RISPERDAL SOLUTION;ORAL risperidone 020588
RISPERDAL TABLET;ORAL risperidone 020272

US Patents and Regulatory Information for risperidone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Heritage Pharma RISPERIDONE risperidone TABLET;ORAL 077769-001 Oct 16, 2008 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sandoz RISPERIDONE risperidone TABLET;ORAL 078528-002 Oct 16, 2009 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Torrent RISPERIDONE risperidone SOLUTION;ORAL 078909-001 Jul 29, 2009 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for risperidone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-001 Oct 29, 2003 ⤷  Try it Free ⤷  Try it Free
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-002 Apr 2, 2003 ⤷  Try it Free ⤷  Try it Free
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-001 Oct 29, 2003 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for risperidone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0196132 94C0008 Belgium ⤷  Try it Free PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Colorcon
Express Scripts
Moodys
Medtronic
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.